NCT02788357

Brief Summary

This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2017

Completed
Last Updated

August 14, 2017

Status Verified

July 1, 2017

Enrollment Period

6.1 years

First QC Date

May 27, 2016

Results QC Date

June 15, 2017

Last Update Submit

July 13, 2017

Conditions

Atomoxetine HydrochloridePlacebos

Keywords

motor trainingmotor recoveryhumanneuroplasticitytranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Fugl Meyer Assessment

    Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.

    baseline, post-intervention, 1-month follow-up

Secondary Outcomes (3)

  • Change in Action Arm Research Test (ARAT)

    baseline, post-intervention, 1-month follow-up

  • Change in Wolf Motor Function Test (WMFT)

    baseline, post-intervention, 1-month follow-up

  • Transcranial Magnetic Stimulation

    Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

Study Arms (2)

Atomoxetine with motor training

EXPERIMENTAL

40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays

Drug: Atomoxetine

Placebo with motor training

PLACEBO COMPARATOR

Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays

Drug: Placebo

Interventions

AtomoxetineDRUG

Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.

Also known as: Strattera
Atomoxetine with motor training
PlaceboDRUG

Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.

Also known as: Sham
Placebo with motor training

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stroke patients
  • Single stroke
  • Chronic (more than 6 months after from stroke)
  • At least 21 years old, but there is no upper age range for this project.
  • Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

You may not qualify if:

  • History of head injury with loss of consciousness
  • History of severe alcohol or drug abuse
  • History of psychiatric illness
  • Unstable cardiac dysrhythmia
  • High blood pressure (systolic pressure \>160 mm Hg and/or diastolic pressure \>100 mm Hg)
  • History of myocardial infarction or unstable angina
  • Pregnancy
  • Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.
  • Subjects using drugs suspected of interfering with plasticity, such as MAOI, alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists, dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ward A, Carrico C, Powell E, Westgate PM, Nichols L, Fleischer A, Sawaki L. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial. Restor Neurol Neurosci. 2017;35(1):1-10. doi: 10.3233/RNN-160673.

    PMID: 27858723DERIVED

MeSH Terms

Interventions

Atomoxetine Hydrochloridesalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Dr. Lumy Sawaki
Organization
University of Kentucky
lsawa2@uky.edu

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 2, 2016

Study Start

November 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

August 14, 2017

Results First Posted

August 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share